| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00442-1 |
| Product Name/Description |
AVANOS MIC-KEY* Gastric-Jejunal Feeding Tube Kits (ENFit)
Multiple Products and Product Codes.
ARTG 248294
(Avanos Medical Australia Pty Ltd - Tube, feeding, jejunostomy) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
AVANOS MIC-KEY* Gastric-Jejunal Feeding Tube Kits (ENFit), product code: 8270-XX-XX, has updated theInstructions for Use (IFU) to include additional complications associated with the use of all AVANOS MIC-KEY* Gastric-Jejunal Feeding Tubes.
Missing information from device labelling can lead to user dissatisfaction and, in this case, not being aware of all potential patient risks associated with use of the device. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Distributors and customers that were directly shipped impacted devices are to download the updated eIFU (electronic Instructions for Use). The Distributor is instructed to send a product defect correction letter to their customers. |
| Contact Information |
0434 564 493 - Susan Warner, Avanos Medical Inc |